CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review
Abstract
Introduction This study aimed to investigate methodological quality of clinical trials in regenerative endodontics and its compliance with the CONSORT statement.Methods An electronic search was performed in 8 electronic databases. Only clinical trials whose participants underwent regenerative endodontic treatment on necrotic permanent immature teeth were included. Quality assessment was performed using the Cochrane Collaboration's Risk of Bias Tool (RoB, version 2.0). Compliance of articles with the CONSORT guidelines was assessed by a tool with scales: 0 = no description, 1 = deficient, and 2 = adequate description, totaling a maximum score of 32 points. The Mann-Whitney and Kruskal-Wallis tests were used to compare the scores among journals, studies, country, income levels, and publication periods. Spearman correlation analyses were performed between CONSORT compliance scores and 2019 journal CiteScore values, publication year, and quality assessment.Results Twenty studies were included. The average CONSORT compliance score was 20.95 (±6.19). The better reported items were the description of the interventions performed in the trials (100%), followed by the description of the number of patients analyzed, losses and exclusions (90%), and the hypothesis tested (85%). Within the 20 studies, 3 articles were classified as "low risk of bias," 8 studies were classified as "some concerns," and 9 studies were considered "high risk of bias." Studies carried out in countries with higher income levels presented higher CONSORT scores. Significant moderate correlations were found between the CONSORT score and the percentage of risk of bias in low-risk domains (r s = 0.63; 95% CI, 0.31-0.94; P = .003) and the overall risk of bias categories (r s = 0.76; 95% CI, 0.54-0.98; P = .001).Conclusions The adequacy of reporting based on the CONSORT checklist items of regenerative endodontic trials was low with a moderate to high risk of bias.
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Several studies in different dental specialties indicate a need for improvement.
“Over time, evidence of the impact of CONSORT has accumulated, and studies have already shown that its endorsement by journals improves the quality of RCT reports in dentistry 6 ; however, several studies in different dental specialties indicate a need for improvement 8 , 15 , 16 , 17 , 18 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [15]
In dentistry, studies have shown that 40% to 52% of the RCTs included in their analyses presented a high risk of bias, indicating inappropriate conduct.
“In dentistry, studies have shown that 40% to 52% of the RCTs included in their analyses presented a high risk of bias, indicating inappropriate conduct 8 , 15 , 18 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [15]
Similar percentages of non-reporting were also observed in areas such as endodontics (40%), pediatric dentistry (64%), and restorative dentistry (60% to 83%).
“Similar percentages of non-reporting were also observed in areas such as endodontics (40%) 15 , pediatric dentistry (64%) 8 , and restorative dentistry (60% to 83%) 16 , 17 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [15]
In dentistry, many authors agree that reporting of RCTs is still suboptimal.
“In dentistry, many authors agree that reporting of RCTs is still suboptimal 15 , 17 , 18 , 30 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [15]
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CONSORT adherence and risk of bias in Randomised Controlled Trials reports on deep caries managementPreprint
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- Authors
- Sponchiado-Júnior, E. C., Vieira, W. D. A., Frozoni, M., Herkrath, F. J., & de-Jesus-Soares, A.
- Affiliations
- Universidade Estadual de Campinas (UNICAMP) (BR)
- Faculdade São Leopoldo Mandic (BR)
- Fiocruz Amazônia (BR)
- ORCID
- Venue
- Journal of Endodontics
- Publisher
- Elsevier BV
- Published
- 2021-11
- Volume
- 47
- Issue
- 11
- Pages
- 1751-1766
- ISSN
- 0099-2399 (ISSN-L)
- OpenAlex
- W3192358103
- Cited by
- 11
- References
- 52
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 4 · 2023: 3 · 2022: 1 · 2021: 1
- FWCI
- 0.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Endodontics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Ministry of Education
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (88887.473221/2020-00)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Dentistry › Oral Surgery › Endodontics and Root Canal Treatments
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- reporting quality, regenerative endodontics, permanent teeth, risk of bias, clinical trial design, CiteScore
- MeSH terms
- Regenerative Endodontics, Humans, Bias, Randomized Controlled Trials as Topic, Checklist
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